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Could a monthly pill replace painful penicillin shots for rheumatic heart disease?

NCT ID NCT07625228

Disease control Sponsor: Ladoke Akintola University of Technology, Ogbomoso, Nigeria Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will test if taking oral azithromycin pills for three days each month works as well as getting a monthly penicillin shot to prevent rheumatic heart disease from getting worse. The trial plans to enroll 474 Nigerian secondary school students aged 10-18 with mild or moderate rheumatic heart disease. Participants will be randomly assigned to either the pill or the shot group and followed for two years to compare disease progression and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Azithromycin (oral) and Benzathine Penicillin G (injection)
What this could lead to
If it works, this could offer a more acceptable, needle-free alternative to monthly penicillin shots for preventing rheumatic heart disease in resource-limited settings.
What could go wrong
This is a non-inferiority trial, meaning it aims to show azithromycin is not worse than penicillin, not necessarily better. The study hasn't started yet, and adherence to oral medication may still be a challenge.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 474 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * They must be between 10 and 18 years old and have a confirmed diagnosis of mild or moderate RHD. * They must be under follow-up care at one of the four trial sites and be capable of attending monthly visits or be picked during routine secondary school screening to be performed as part of the study. * At enrollment, patients must demonstrate cognitive capacity to consent (or assent, if a minor) and a willingness to adhere to the study schedule. * Females of childbearing potential must agree to avoid pregnancy during the trial. * Individuals must not have initiated any alternative RHD prophylaxis regimen before enrollment; the trial will provide all prophylaxis during the study Exclusion Criteria: * known allergy to penicillin or any history of anaphylaxis to antibiotics. * Girls who are pregnant or breastfeeding will be excluded, as well as any patient with severe comorbidities likely to complicate prophylaxis or follow-up. For example, patients with advanced heart failure (NYHA class III-IV), significant chronic kidney or liver disease, uncontrolled diabetes, or other serious chronic illnesses (e.g. active tuberculosis, immunodeficiency). * Patients with psychiatric conditions or cognitive impairment that preclude informed consent or reliable adherence will also be excluded. * Any patient currently enrolled in another interventional trial, or who is unwilling or unlikely to comply with monthly visits, will be excluded.

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Conditions

The condition(s) this trial relates to.

heart valve disorder rheumatic heart disease rheumatic fever prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rheumatic fever Valvular cardiomyopathy Valvular heart diseases

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.